Comparison of Successful Spinal Needle Insertion Between Obese and Non-obese Pregnant Women in Crossed Leg Sitting Position Undergoing Caesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 4
- 主要终点
- Number of successful spinal needle placement in the first attempt
研究概览
简要总结
The study aimed to compare successful spinal needle insertion between obese and non-obese pregnant women in crossed leg sitting position undergoing cesarean section
详细描述
Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study.Subjects sat in cross leg sitting position: patients sit with both thighs abducted, knees flexed medially, each feet soles were under their contralateral thighs. The back was flexed maximally, subjects' chin approaching the sternum, and subjects hugged a pillow. Lumbal puncture was done using Quincke needle 25G/27G at L4-5 intervertebral gap until the it reached subarachnoid space (confirmed by free flow cerebrospinal fluid). Data recorded were the number of attempt for the successful spinal puncture, the number of spinal needle-bone contact and blood vessel puncture incidence. Data was analyzed by using Statistical Package for Social Scientist (SPSS), for numerical data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square test or Fischer Exact's Test. Data normality was tested by Kolmogorov-Smirnov test. Significant value is p<0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18-45 years old, with American Society of Anesthesiologists (ASA) physical status I-III who were planned to undergo caesarian section with spinal anesthesia in crossed leg sitting position.
- •Subjects have been explained about the study, have agreed to enroll and have signed the informed consent form
排除标准
- •Subjects with contraindications for spinal anesthesia
- •Subjects with fetal's head trapped, umbilical prolapse, and foot presentation
- •Subjects with pre-eclampsia
- •Subjects with cardiovascular diseases
- •Subjects with scoliosis
- •Subjects with recent lumbal surgery history
- •Subjects who cannot sit in crossed leg sitting position.
- •Drop out criteria:
- •Subjects with worsening conditions before spinal anesthesia
- •Subjects with failed spinal needle insertion and thus received general anesthesia
- •Subjects with twin pregnancy
- •Subjects drop out the study.
结局指标
主要结局
Number of successful spinal needle placement in the first attempt
时间窗: 2 months
The number of successful spinal needle placement in the first attempt was recorded in yes/no method.
The number of needle-bone contact
时间窗: 2 months
The number of spinal needle-bone contact
次要结局
- The number of blood vessel puncture incidence.(2 months)
研究者
Susilo Chandra
Anesthesiologist Consultant
Indonesia University